A Multicentered, Double-blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Procaterol Hydrochloride With Inhaled Glucocorticoid in Treatment Patients With Cough Variant Asthma (CVA)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Patient cough symptom score
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of procaterol hydrochloride with inhaled glucocorticoid in treatment patients with cough variant asthma (CVA).
详细描述
This is a 8-week, double-blind, randomized, placebo-controlled study, the patients with CVA will be randomized to experimental or placebo control group.
During the screening period, eligible patients will be evaluated by cough symptom score and LCQ life quality score. After 4 and 8 weeks treatment, patients will be evaluated by cough symptom score and LCQ life quality score respectively. Adverse events will also be captured at every visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female patients,18-75 years old;
- •cough lasting over 3 weeks ; dry cough or with slight white mucous phlegm; cough is the main clinical symptom or the only symptom;
- •without wheeze and fever;
- •without the history of upper respiratory tract infection within recent two months; non-smoking or giving-up smoking for over two years;
- •without rales from lung;
- •no obvious abnormalities from chest X-ray;
- •bronchial provocation test: positive.
排除标准
- •patients with chronic pulmonary disease;
- •patients who are allergic to ß2 receptor agonist;
- •patients taking ß2 receptor agonist for long time;
- •severe heart, renal and hepatic disease;
- •unable to comply with the protocol;
- •pregnant, breast feeding, and childbearing potential women;
- •patients improper to the trial according to the investigators' judgment.
研究组 & 干预措施
I. Procaterol Hydrochloride
Meptin (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;
干预措施: Procaterol hydrochloride (Drug)
II. Procaterol hydrochloride placebo
Meptin placebo (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;
干预措施: Meptin placebo (Drug)
结局指标
主要结局
Patient cough symptom score
时间窗: 8 weeks
Therapy duration
时间窗: 8 weeks
Rates of adverse events
时间窗: 8 weeks
次要结局
- LCQ Life Quality Score(8 weeks)